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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Medconn Glycated Hemoglobin Test system

    K Number: K242911 · Decision Jun 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    269

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    Basic Information

    Device Name
    Medconn Glycated Hemoglobin Test system
    K Number
    K242911
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1373
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Medconn Medical Technology Co., Ltd.
    Date Received
    September 24, 2024
    Decision Date
    June 20, 2025
    Product Code
    PDJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PDJ Hemoglobin A1c Test System

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    Other Clearances by Shanghai Medconn Medical Technology Co., Ltd.

    K Number Device Name
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